Dermatop Ointment

WARNINGS

No information provided.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids can produce
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the
potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be
produced in some patients by systemic absorption of topical corticosteroids
while on treatment. Patients receiving a large dose of a higher potency topical steroid applied to a large surface area or under occlusion should be evaluated
periodically for evidence of HPA-axis suppression. This may be done by using
the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

DERMATOP Ointment (prednicarbate ointment) 0.1% did not produce significant HPA-axis
suppression when used at a dose of 60 grams per day for a week in patients with
extensive psoriasis or atopic dermatitis.

However, if HPA-axis suppression is noted, an attempt should
be made to withdraw the drug, to reduce the frequency of application, or to
substitute a less potent corticosteroid. Recovery of HPA-axis function is
generally prompt and complete upon discontinuation of topical corticosteroids.
Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur
requiring supplemental systemic corticosteroids. For information on systemic
supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity
from equivalent doses due to their larger skin surface to body mass ratios.
(See PRECAUTIONS-Pediatric Use.)

If irritation develops, DERMATOP Ointment (prednicarbate ointment) 0.1% should be
discontinued and appropriate therapy instituted. Allergic contact dermatitis
with corticosteroids is usually diagnosed by observing failure to heal rather
than noting a clinical exacerbation as with most topical products not
containing corticosteroids. Such an observation should be corroborated with
appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an
appropriate antifungal or antibacterial agent should be used. If a favorable
response does not occur promptly, use of DERMATOP Ointment (prednicarbate
ointment) 0.1% should be discontinued until the infection has been adequately
controlled.

Laboratory Tests

The following tests may be helpful in evaluating patients
for HPA-axis suppression:

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In a study of the effect of prednicarbate on fertility,
pregnancy and postnatal development in rats, no effect was noted on the
fertility or pregnancy of the parent animals or postnatal development of the
offspring after administration of up to 0.80 mg/kg of prednicarbate
subcutaneously.

Prednicarbate has been evaluated in the Salmonella reversion
test (Ames test) over a wide range of concentrations in the presence and
absence of an S-9 liver microsomal fraction and did not demonstrate mutagenic
activity. Similarly, prednicarbate did not produce any significant changes in
the numbers of micronuclei seen in erythrocytes when mice were given doses
ranging from 1 to 160 mg/kg of the drug.

Pregnancy

Teratogenic effects - Pregnancy Category C

Corticosteroids have been shown
to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. Some corticosteroids have been shown to be teratogenic
after dermal application in laboratory animals.

Prednicarbate has been shown to be teratogenic and
embryotoxic in Wistar rats and Himalayan rabbits when given subcutaneously
during gestation at doses 1900times and 45times, respectively, the recommended
topical human dose, assuming a percutaneous absorption of approximately 3%.

In the rats, slightly retarded fetal development and an
incidence of thickened and wavy ribs which was higher than the spontaneous rate
were noted.

There are no adequate and well-controlled studies in
pregnant women on teratogenic effects of prednicarbate. Therefore, DERMATOP
Ointment (prednicarbate ointment) 0.1% should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human
milk and could suppress growth, interfere with endogenous corticosteroid
production, or cause other untoward effects. It is not known whether topical
administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in human milk. Because many drugs
are excreted in human milk, caution should be exercised when DERMATOP Ointment
(prednicarbate ointment) 0.1% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of DERMATOP Ointment (prednicarbate ointment) 0.1% in
pediatric patients below the age of 10 years have not been established. Because
of a higher ratio of skin surface area to body mass, pediatric patients are at
a greater risk than adults of HPA axis suppression when they are treated with
topical corticosteroids. They are therefore also at greater risk of
glucocorticosteroid insufficiency after withdrawal of treatment and of
Cushing's syndrome while on treatment. Adverse effects including striae have
been reported with inappropriate use of topical corticosteroids in pediatric
patients. (See PRECAUTIONS.)